Completed
The Forum on Neuroscience and Nervous System Disorders held a public workshop on June 16, 2009 to examine data collection of suicidality in central nervous system clinical trials. Individuals from the FDA, pharmaceutical industry, academia, NIH, and advocacy groups were invited to make presentations and stimulate discussions focused on how best to integrate the current tools for data collection with current methods of data analysis.
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Workshop
·2010
The Food and Drug Administration (FDA) now requires that all clinical trials for drugs that affect the central nervous system—including psychiatric drugs—are assessed for whether that drug might cause suicidal ideation or behavior. The Institute of Medicine's (IOM) Forum on Neuroscience and Nervous...
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Description
An ad hoc committee will plan and host a public workshop inviting individuals from the FDA, pharmaceutical industry, academia, NIH, and advocacy groups to make presentations and stimulate discussions focused on how best to integrate the current tools for data collection with current methods of data analysis. In addition, the workshop participants will discuss opportunities for potential partnerships with various stakeholders. Specifically, participants will be invited to present and discuss information that will:
- Review available data on the extent to which emergent suicidal ideation predicts the occurrence of actual suicidal behavior particularly in the short-term.
- Ascertain optimal methods of analysis to address if suicidal ideation predicts the short-term occurrence of actual suicidal behavior.
- Examine potential partnerships between the FDA, pharmaceutical industry, academia, and the NIH that could be used to facilitate data-sharing from randomized clinical trials.
An individually authored summary of the workshop will be prepared in accordance with institutional policy and procedures.
Collaborators
Committee
Robert D. Gibbons
Co-Chair
William Z. Potter
Co-Chair
Charles M. Beasley, Jr.
Member
David A. Brent
Member
Yeates Conwell
Member
Walter J. Koroshetz
Member
Thomas P. Laughren
Member
Husseini K. Manji
Member
David Michelson
Member
Atul C. Pande
Member
Philip S. Wang
Member
Sponsors
Department of Health and Human Services
National Science Foundation
Private: For Profit
Private: Non Profit
Staff
Bruce Altevogt
Lead
Clare Stroud
Lead
Major units and sub-units
Health and Medicine Division
Lead
Institute of Medicine
Lead
Board on Health Sciences Policy
Lead